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Ortho Evra® Defects

Ortho Evra® defects have prompted serious concern since the publication of studies linking the contraceptive to fatal blood clots and cardiovascular complications. The Ortho Evra® birth control patch is the first contraceptive of its kind to gain FDA approval. Since its 2001 approval, Ortho Evra® has been aggressively marketed by its maker, Ortho McNeil. Recent reports of serious Ortho Evra® defects have prompted serious concern and scrutiny of the drug's maker.

It is alleged that Ortho McNeil learned of dangerous Ortho Evra® defects before this medication was approved and that, once approved, the company failed to warn consumers about the risks associated with their product. In a pre-marketing Ortho Evra® trial involving over 3,000 participants, Ortho McNeil discovered two cases of women who developed blood clots that traveled to their lungs, a life-threatening condition called pulmonary embolism. Some medical experts believed these injuries might have been related to Ortho Evra® defects, yet the medication was still approved for consumer use.

Despite these pre-market findings, Ortho McNeil has taken no steps to further investigate the possibility of Ortho Evra® defects that may pose a serious threat to consumers. In 2005, the Associated Press conducted an analysis of the FDA's database of Ortho Evra® adverse drug reports. The organization discovered nearly ten thousand reports of adverse reactions to the birth control patch. In just one year, the FDA received 44 reports of death or serious injury linked to Ortho Evra® defects.

Based on their findings, the Associated Press concluded that using the birth control patch tripled a woman's risk of developing a blood clot and related complications. Ortho McNeil states that this report is over-exaggerated. According to AP calculations, an Ortho Evra® user has a three in 200,000 chance of developing a blood clot as a result of this medication. For comparison, oral contraceptives carry one in 200,000 risk of developing blood clot related complications.

At least 23 deaths have been linked to Ortho Evra®, 17 of which were caused by blood clot complications. Most of the women who have died were young, healthy, and had no history of cardiovascular conditions. Ortho Evra® defects have been linked to the deaths of women as young as 18 years old. Ortho McNeil announced they are investigating the possibility of Ortho Evra® defects that may lead to serious patient injury or death.

While the exact link between Ortho Evra® and serious cardiovascular complications remains unknown, some medical experts have expressed their professional opinion about Ortho Evra® defects. They believe the increased risk of serious health problems may be related to the Ortho Evra® delivery system. Oral contraceptives are first processed through the digestive system before hormones enter the blood stream. With the Ortho Evra® patch, similar hormones are delivered directly into the blood stream. This may result in a surge of harmful hormones flooding a patient's system thereby causing deleterious effects. If you would like to learn more about Ortho Evra® defects, please contact us to speak with a qualified attorney.

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